“Why the Clinical Evaluation Plan & Report is Your Gateway to Market Entry”

3 September 2025 | 4 – 5 pm (CEST) | Webinar

This exclusive session will reveal why the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are not just paperwork — they are the foundation of your MDR/IVDR market approval.

What You’ll Learn:

Regulatory Roadmap for AI Medical Devices

• CE Marking, MDR/IVDR essentials, and AI-specific challenges like adaptive algorithms, bias mitigation, and data integrity
• Role of Quality Management Systems

Budgeting for Success

• Cost drivers from prototyping to post-market surveillance, and how early regulatory decisions affect long-term budgets

Clinical Trials 101

• When trials are needed, their key stages, and AI-specific challenges such as dataset representativeness and performance drift

CEP & CER – Your Clinical Evidence Backbone

• Purpose, structure, evidence sources, and strategies to meet MDR safety, performance, and benefit-risk requirements

Case Study: From Concept to Market

• A condensed example of an AI device journey from classification to market, highlighting budget and evidence development

SPARK Poland invites You to join our webinar on September 3^rd at 16:00 CEST. Online via Zoom. Please register here. The webinar will be hosted by SPARK Denmark.

Please note that you will receive the meeting link and access code the evening before the lecture and that access to last minute registrations, cannot be guaranteed.